Trinity Biomedical is a medical device contract manufacturer located in Menomonee Falls, WI specializing in cleanroom assembly, CNC machining, wireforming, and ultrasonic washing. They support customers from prototype to high volume production with capabilities such as Class 6-8 cleanrooms, CNC milling and Swiss turning, waterjet cutting, wire EDM, and spring making. Trinity aims to be a global leader in medical component manufacturing and strives to continually improve quality and responsiveness for their customers.

1. Trinity Biomedical, Inc.
W175 N5750 Technology Drive
Menomonee Falls, WI. 53051
www.trinitybiomedical.com
P: 262-252-4786 F:262-252-4791

2. Medical Device Contract
Manufacturing
Trinity Biomedical supports the Medical Device industry by specializing in cleanroom device
assembly, CNC wireforming, advanced machining, automated ultrasonic washing and
passivation, systems’ automation building, along with a technically advanced staff.
With Trinity's broad array of capabilities, foremost attention to quality, responsiveness and lean
operation we can either supply a single component or the entire device with a speed to market
timeline matched by few.
Trinity offers a state-of-the-art US Fed STD 209E Class ISO-6 / ISO-7 / ISO-8 cleanroom
dependent on your needs and requirements. Trinity is supported by ISO 9001-2008 and
ISO13485; we are also AS-9100 compliant.
Trinity supports volume requirements from one to 400M articles. Sourcing your needs to Trinity
Biomedical provides you the means to quickly accomplish the development and manufacturing
of medical devices for today’s global markets without major investments of people and capital
within your organization.
Company Overview

3. Medical Device Contract
Manufacturing
Our Vision
Trinity Biomedical, Inc. will strive to be a
global leader in the creation and production
of medical components to meet the needs of
the medical device industry.
Our Mission
Our Team is committed to supporting the
medical manufacturing industry resulting in
an improved quality of human life.
Our Quality Policy
Trinity Biomedical is committed to surpass all
of our customer’s quality expectations
through effective quality objectives and an
enthusiastic drive to continually improve all
aspects of the organization.
Trinity Biomedical’s Path to Success

4. Medical Device Contract
Manufacturing
Our Certifications
▪ Med device experience since 1965
▪ 20 years CNC medical machining
▪ 21 years cleanroom assembly
▪ 21 years medical wire forming
▪ 23 years medical wire EDM
▪ 48 years medical tool manufacture
▪ FDA regulatory experience
■ ISO 9001:2008
■ ISO 13485:2003
■ ISO 146144.1 Class 6 Cleanroom
■ AS-9100 Compliant

5. Medical Device Contract
Manufacturing
Our Capabilities
■ 52,000 ft2 Manufacturing facility
■ Class 1000 - 100,000 Cleanroom
■ Lab Testing - particulate, non-volatile residue
■ CMM Lab Inspection
■ Statistical Process Control
■ Reverse Engineering
■ Product Research & Development
■ Rapid Prototype Development
Our Processes
■ CNC Milling & Swiss Turning
■ Dynamic Waterjet
■ Wire EDM
■ Wire & Spring Forming
■ Metal Stamping
■ Multi-Sonic Washing & Citric Passivation
■ Cleanroom Assembly & Packaging
■ Warehouse & Distribution

6. Medical Device Contract
Manufacturing
Our Processes - CNC Milling & Swiss Turning
Trinity Biomedical is heavily invested in modern CNC
machining equipment. We have advanced the process
of prototype and production stage quantities of medical
components to new levels of speed and precision:
■ Machine travels up to 85”X 50” X 36” (x, y, z).
Parts up to 116” long.
■ Spindles up to 20,000 RPM for true,
high speed machining.
■ 1000 PSI thru-the-spindle coolant.
Drilling speeds up to 7x faster
than with HSS drills.
■ Shrink-fit tool holders for the ultimate in
machine tool accuracy and rigidity.
■ Software tool-pathing can reduce cutting times up to
50%.
■ Tool position tolerances are generally to within
0.0005”.

7. Medical Device Contract
Manufacturing
Our Processes - Water Jet Capabilities
Trinity Biomedical’s dynamic, abrasive water jet
cutting system brings high tolerance, rapid
cutting to a new level. This versatile 4-axis head
provides 3-dimensional cutting head movement.
Its 60,000 PSI, dynamic cutting head can provide
reduced cutting times up to 70% and provide
walls with zero taper. Edges are smooth, heat-
zone free and accurate to within 0.003”.
We are experienced in cutting steel, aluminum,
titanium, brass, composite material, glass,
plastic, ceramic tile, rubber, granite, and marble.
Capable of material cut up to 9" thick with a
table travel of 6' x 12’.

8. Medical Device Contract
Manufacturing
Our Processes - Wire EDM
As a full service EDM source, we
specialize in precision machining with
quick turn-around using the following:
■ state-of-the-art submersible
machines w/ automatic
wire threading
■ 30” x 20” x 14” machine travel
■ Wire Ø down to 0.004”
■ Drilling Ø 0.008 to 0.250”
■ Solid Modeling
■ In-house block prep & heat treat

9. Medical Device Contract
Manufacturing
Our Processes – Wire Forming
Trinity Biomedical has 25 years of experience
in Wire Forming:
■ Wind Wire, Coil Wire, Form Wire as small
as 0.0001 mm.
■ Tension and Pitch Controls, along with
variation w/in single wound or
coiled length.
■ Cannula Reinforcement Wires
■ Coil-Reinforced Tubing for Catheters
■ Introducer wires, Suture snare wires
■ Compression / Extension / Torsion springs
■ Exotic materials specialists: Titanium,
Inconel, Beryllium, Elgiloy, Chrome Vanadium, AL
Vanadium, AL 286, etc.
■ Electroplating, Tumbling, Shot Peen & Passivation

10. Medical Device Contract
Manufacturing
Our Processes – Spring Making
Trinity Biomedical manufactures springs for a range
of medical device applications including:
■ Implants ■ Dispensers
■ Hearing Aids ■ Diagnostic Equipment
■ Pacemakers ■ Monitoring Devices
■ Urology ■ Device Manufacturing
■ Pumps ■ Guide Wires
Various surface treatments are available including:
■ tempering, hardening & annealment
■ ultrasonic cleaning, passivation, deburing &
shot peening
■ zinc, phosphate, powder coating and color
topcoat

11. Medical Device Contract
Manufacturing
Our Processes – Metal Stamping
Trinity Biomedical has 46 years experience in the production
Medical Metal Stampings:
■ Complex, intricate and close tolerance components
■ Short, medium and high production volumes
■ Phenolic stampings
■ Titanium, inconel, beryllium and other
exotic metals
■ Rapid prototyping

12. Medical Device Contract
Manufacturing
Our Processes – Rapid Prototyping
At Trinity Biomedical, we place significant emphasis on Rapid Prototyping response for our
customers.
Whether it is a precise machined component, an intricate stamping, a medical instrument or
a first-to-market assembly, we are here to quickly respond to your needs and requirements.
For the medical industry, we specialize in
the following types of prototyping:
■ Surgical tools / instruments
■ Medical devices
■ Medical components
■ Hypo- Tubes
■ Implants
■ Medical Poly Drape sealing
■ CNC machined, waterjet,
EDM components
■ Stampings, springs and
wire forms

13. Medical Device Contract
Manufacturing
Our Processes - Multi-Sonic Washing
Trinity Biomedical is an industry leader in
ultrasonic washing. Our state-of-the-art washers
are capable of U/S frequencies of 25, 40, 72 and
104 kHz.
Water purity is the key ingredient to the success
of our process. Using a Reverse Osmosis de-
ionized water treatment system capable of
achieving 18 meg ohms of purity, we are a
leader in the field of washing.
Trinity has capabilities to qualify all of our
washing techniques using one or all of the
following test methods:
■ particulate testing
■ non-volatile residue testing
■ testing for bioburden & endotoxin

14. Medical Device Contract
Manufacturing
Our Processes - Cleanroom Passivation
Trinity Biomedical offers a citric acid passivation
service within an ISO Class 6 Cleanroom suitable for
implantable components.

15. Medical Device Contract
Manufacturing
Our Processes – Cleanroom Assembly
Trinity Biomedical assembly options include:
■ Medical Device & Instruments
■ Multi-Component Assemblies
■ Thermo Soldering
■ Ultraviolet Gluing
■ Tig / Mig Welding
■ Laser Welding
■ Medical Kits
■ Surgical Kits
■ Emergency Kits

16. Medical Device Contract
Manufacturing
Our Processes – Cleanroom Packaging
Trinity Biomedical cleanroom packaging
options include:
■ Package Design & Development
■ Manual Bagging
■ Kit Packaging
■ Bulk Packaging
■ Tray Sealing
■ Skin Pack
■ Coating
■ Over Packing
■ Pouch Sealing
■ Bar Coding
■ Labeling
Our ISO 14644.1 Class 1000 cleanroom provides high
level manufacturing, cleaning and packaging capabilities.
Trinity Biomedical offers years of experience in the
assembly of ultra fine wires, guidewires, catheters,
electronics, aerospace and machined medical devices.

17. Our Products & Services
Medical Device Contract
Manufacturing
Trinity Biomedical houses a 2500 ft2 convertible Class 1000 –
100,000 clean room for your Ultrasonic Washing / Passivation,
assembly and packaging requirements. We are capable of
handling all your production programs as well as managing
the entire process from prototype through production.
Programs are run in secure private assembly
rooms when requested.
Services Offered Include:
■ Medical Device Washing and Assembly
■ Precision Contract Manufacturing
■ Precision Component Assembly
■ Clean Room Packaging Services
■ Contract Ultrasonic Washing & Packaging

18. Medical Device Contract
Manufacturing
Product Development and Management
Critical elements within the design and management
stages include:
■ Refinement of Customer Goals into Final ProductRefinement of Customer Goals into Final Product
■ In House DesignIn House Design –– SolidWorks and AutoCad.SolidWorks and AutoCad.
■ Extensive Knowledge of Metrologic FunctionsExtensive Knowledge of Metrologic Functions
■ Fixture and Process Qualification and ValidationFixture and Process Qualification and Validation
■ Tool Procurement with Design OversightTool Procurement with Design Oversight
■ Eight InEight In--House Project ManagersHouse Project Managers
■ Six InSix In--House DesignersHouse Designers
Early Trinity Biomedical involvement with your product
at the initial design stage can yield enhanced quality
and functionality to new product developments.
Improved manufacturability and optimization of material
usage have the potential to generate competitive
advantages to your Company.

19. Medical Device Contract
Manufacturing
Medical Component Images

20. Medical Device Contract
Manufacturing
Medical Component Images

21. Our Associations
Medical Device Contract
Manufacturing

22. Medical Device Contract
Manufacturing
Contact Information
■ Tom McAdams General Manager
tmcadams@trinitybiomedical.com
Cell: 262-389-2458
Office: 262-252-4786
Fax: 262-252-4791
Our Ultimate Goal & Objective
To leverage our 46 years experience, our accumulated lean
manufacturing practices, innovation and technology, so that we
deliver our to customers quality components within industry
leading timelines.
We Absolutely Stand Behind Our Products & Commitments